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Back|NCT06651580Recruiting
Official Title

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Sponsor
M.D. Anderson Cancer Center
Enrollment
1,600
Timeline
Apr 2021 → Feb 2027
About This Study

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • 1All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
  • 2Subjects/parents must have signed an authorization for the release of their or their child's protected health information
  • 3All children must be under 18 years of age at the time of enrollment
  • 4Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
  • 5Abdominal pain compatible with AP
  • 6Serum amylase and/or lipase values \>= 3 times upper limits of normal
  • 7Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
  • 8ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a \>= 1 month pain-free interval between episodes
  • 9Chronic Pancreatitis:
  • 10Children with at least:
  • 11One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes
  • 12Irreversible structural changes:
  • 13Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound \[abd US\], magnetic resonance imaging/magnetic resonance cholangiopancreatography \[MRI/MRCP\], computerized tomography \[CT\], endoscopic retrograde cholangiopancreatography \[ERCP\], endoscopic US \[EUS\])
  • 14Ductal obstruction or stricture/dilatation/irregularities that are persistent (for \>= 2 months) on any imaging
  • 15Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP
  • 16Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)

Exclusion Criteria

  • 1Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions

Locations

26 sites participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Reuven "Zev" Cohen

Children's Hospital Los Angeles

Los Angeles, California 90027

Recruiting

Yuhua Zheng

Cedars Sinai Medical Center

Los Angeles, California 90048

Recruiting

Quin Liu

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →